MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, it was observed that there is a more noticeable coating on the inside of the reservoir compared to the (b)(6) reservoir.It has not impacted the function, just concerned.No known impact or consequence to patient.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on october 20, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (b)(4).The sample was not returned for evaluation; however, a photo was provided showing the visual anomaly reported.There appears to be a hazy look to the inside of the reservoir, resembling condensation, with a slight pattern in certain areas.As the lot number of the affected product was not provided, a list of all 3cx*rx25re products sent to australia in the past 6 months was obtained.Retention samples from this list of product were visually inspected and confirmed to not have this extra coating visual anomaly.Two of the retention samples were then placed into an accelerated aging oven for approximately 24 hours, in order to get warm, and then immediately placed into a refrigerator, in attempts to replicate the condensation; however, no condensation appeared on the units.During blood testing using an expired unit from lot ql17, a similar effect was seen after bovine blood was introduced into the reservoir.The anomaly did not last on the reservoir after the test was completed.Although a definitive root cause could not be determine, this event has been confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6045070
• MDR Text Key: 57986077
• Report Number: 1124841-2016-00359
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1